NCT02915588

Brief Summary

The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

September 15, 2016

Last Update Submit

September 23, 2016

Conditions

Full Thickness Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Change of Constant Murley Score

    Timepoints: Before surgery; 6, 12, 24 weeks after surgery

    up to 24 weeks

Secondary Outcomes (4)

  • Change of DASH Score

    up to 24 weeks

  • Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)

    up to 24 weeks

  • Change of Pain (max; average; rest)

    up to 24 weeks

  • Change of Strength (abduction; external Rotation)

    up to 24 weeks

Study Arms (2)

Primary Active

ACTIVE COMPARATOR

Early postoperative isometric activation of the rotator cuff

Other: early isometric loading after rotator cuff surgery

Primary Passive

ACTIVE COMPARATOR

Standard postoperative passive movement rehabilitation protocol

Other: passive motion after rotator cuff surgery

Interventions

early isometric loading after rotator cuff surgeryOTHER
Primary Active
passive motion after rotator cuff surgeryOTHER
Primary Passive

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgery of the rotator cuff after full thickness tear
  • informed consent
  • understanding german language

You may not qualify if:

  • previous surgery of the shoulder
  • neurological or systemic diseases with impairment of shoulder function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Hospital

Linz, 4020, Austria

Location

Study Officials

  • Christian Mittermaier, Dr

    Institute of physical medicine and rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 27, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 27, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)